Associate Director - Biostatistics

3 days ago

🏖️ New Jersey – Remote

Although this job is listed in New Jersey, this company may be open to hiring remote in other states.

💵 $160k - $210k / year

⏰ Full Time

🟠 Senior

👔 Director

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Mitsubishi Tanabe Pharma America

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Mitsubishi Tanabe Pharma America is a dedicated pharmaceutical company focused on developing innovative treatments for serious and debilitating diseases, with a strong commitment to addressing unmet medical needs in conditions such as amyotrophic lateral sclerosis (ALS) and Parkinson's disease. The company actively engages in research and collaboration to advance effective options for healthcare providers, aiming to enhance the quality of life for patients facing significant health challenges.

pharmaceutical products • amyotrophic lateral sclerosis • rare disease • innovation • research and development

51 - 200 employees

Founded 2016

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• Responsible for providing statistical support to clinical development projects within designated therapeutic areas at MTPA. • Provides leadership to internal and/or consultant biostatistical staff. • Provides statistical support for assigned therapeutic areas with multiple projects throughout the complete product lifecycle, from clinical program design to product market and publication. • Contributes to the design, conduct, analysis, and interpretation of clinical studies and research projects. • Performs as project statistician for assigned therapeutic areas/products. • Provides sample size estimates and power calculations for complex study designs. • Reviews protocols and case report forms for soundness and quality of trial design. • Jointly develops statistical methodology sections of protocol. • Performs inferential (predictive) analysis. • Participates in evaluating the relevant parts of bid proposals from external service providers, as well as contractual and service agreements. • Oversees CRO deliverables for contracted statistical services. • Provides statistical components of regulatory submissions. • Assists the Department Head in the preparation of documents for submission to regulatory authorities including, but not limited to: Investigational Drug Applications (IND), New Drug Applications (NDA), Annual Reports, and other reports as required. • Evaluates the objectives, performance, career and training needs of his/her biostatistics associates in cooperation with the Department Head. • Participates in process and technical improvement initiatives. • Participates in review and updating of established statistical SOPs and working practices. • Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process. • Performs other departmental duties as assigned.

🎯 Requirements

• Minimum M.S. in statistics, biostatistics or equivalent in a closely related field required • Minimum of 6 (if Ph.D.) or 8 (if M.S.) years biostatistics experience in the pharmaceutical industry • Experience with NDA/MAA submissions • Experience as a sponsor representative at FDA/EMEA meetings • Excellent statistical knowledge and project planning skills • Knowledge of clinical trial research and regulatory requirements • Familiarity with SDTM/AdaM CDISC guidance for submissions • Knowledge of eCTD • Strong interpersonal and communication skills and ability to collaborate effectively with other groups in a matrix organization

🏖️ Benefits

• Medical and Dental health benefits • Short-term and long-term disability plans • Company Paid and Supplemental Life insurance • Additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection • Generous PTO policy commencing with 24 PTO days, pro-rated based on hire date